ПФА-6/7
Registration CertificateIntended for coagulological determination of the presence of LA (Lupus Anticoagulant) in patients' blood plasma, based on the criteria set by the Subcommittee on Science and Standardization of the International Society on Thrombosis and Hemostasis.
In the pathogenesis of antiphospholipid syndrome, the leading role is played by the presence of Lupus Anticoagulant (LA), a group of similar blood coagulation inhibitors belonging to the immunoglobulin classes IgG and IgM. Their presence leads to the development of both arterial and venous thromboses in the context of various diseases such as systemic lupus erythematosus, rheumatoid arthritis, etc.
Furthermore, Lupus Anticoagulant is associated with various pregnancy pathologies, such as miscarriage, fetal growth restriction syndrome, and stillbirth.
Method Principle:
In the first stage, tests are conducted to detect LA, using reagents with low phospholipid content to amplify the difference between normal and pathological plasma (screening tests).
To ascertain the nature of the inhibitors, further tests are conducted with reagents containing high concentrations of phospholipids or platelet membranes to deplete the anticoagulant effect of LA (confirmatory tests). Shortening of the coagulation time in this case will indicate the presence of LA in the studied plasma.
Kit Components:
One LA Test kit is designed for the determination of the presence of LA in no fewer than 40 patient plasma samples.
The accuracy of Lupus Anticoagulant detection should be verified using control plasma containing Lupus Anticoagulant.